NCT02946983

Brief Summary

The investigators will test whether a subliminal, intragastric dose of fructose is able to influence the emotional state at the behavioural and neural level, as has been previously shown for fatty acids. They will also examine the potential involvement of gut peptide release. Based on previous research using fatty acids, an attenuating effect of fructose compared to placebo on the induced negative emotional state is hypothesized at the self-report as well as the brain level.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
Last Updated

October 27, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 12, 2016

Last Update Submit

October 26, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Functional brain images

    Changes in brain responses after administration of our test solution compared to baseline will be assessed via functional magnetic resonance imaging

    From the start of the study until the endpoint of the study, with a total duration of 50 minutes

Secondary Outcomes (3)

  • Hunger scores

    every 10 minutes since the scan starts until 40 minutes after the start of the scan

  • Mood assessment via the Self Assessment Manikin questionnaire

    every 10 minutes since the scan starts until 40 minutes after the start of the scan

  • Gut hormone levels

    every 10 minutes since the scan starts until 40 minutes after the start of the scan

Study Arms (4)

Fructose - Neutral emotion condition

ACTIVE COMPARATOR

Intragastric infusion of fructose with neutral emotion induction

Other: Fructose

Fructose - Sad emotion condition

ACTIVE COMPARATOR

Intragastric infusion of fructose with sad emotion induction

Other: Fructose

Placebo - Neutral emotion condition

PLACEBO COMPARATOR

Intragastric infusion of distilled water with neutral emotion induction

Other: Control

Placebo - Sad emotion condition

PLACEBO COMPARATOR

Intragastric infusion of distilled water with sad emotion induction

Other: Control

Interventions

FructoseOTHER

Intragastric administration of fructose (25g dissolved in 250ml distilled water)

Fructose - Neutral emotion conditionFructose - Sad emotion condition
ControlOTHER

Intragastric administration of distilled water

Placebo - Neutral emotion conditionPlacebo - Sad emotion condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers (N=15)
  • Male and female
  • Age 18 - 60
  • Body Mass Index (BMI) of 20 - 25 kg/m2
  • Stable body weight for at least 3 months prior to the start of the study

You may not qualify if:

  • Abdominal or thoracic surgery. Exception: appendectomy
  • Gastrointestinal, endocrine or neurological diseases. Exception: IBS if the participant will be recruited in the patient group
  • Cardiovascular, respiratory, renal or urinary diseases
  • Hypertension
  • Food or drug allergies
  • Anemia
  • Eating disorders
  • Psychotic disorders
  • Depressive disorders
  • Emotional and/or restraint eating
  • No medication on a regular basis, exception: oral contraception
  • No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
  • Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
  • Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, …
  • Pregnant or breastfeeding women
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Iven J, Biesiekierski JR, Zhao D, Tack J, Van Oudenhove L. Intragastric fructose administration interacts with emotional state in homeostatic and hedonic brain regions. Nutr Neurosci. 2022 Mar;25(3):581-592. doi: 10.1080/1028415X.2020.1781326. Epub 2020 Jun 19.

    PMID: 32558624DERIVED

MeSH Terms

Interventions

Fructose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Jan Tack, Prof

    University of Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

October 27, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share